Director, Global Regulatory Sciences
SciPro have partnered with a global pharmaceutical business who are looking for an experienced Regulatory professional to join their growing organisation. The company are focused on developing innovative solutions to transform the lives of patients through their pioneering technology. With an impressive pipeline, the organization works across a number of therapeutic areas, particularly in areas of high unmet medical need. This role will be a part of the team focusing on Cell Therapy and will be responsible for defining the regulatory strategy across Europe, being the main point of contact for interactions and negotiations with the EMA and ensuring the translation and execution of the strategy across the region to meet business objectives.
- Be the main point of contact for interactions with the EMA
- Develop regulatory strategy across the region and ensure high quality execution to meet business objectives
- Effectively communicate with internal and external stakeholders
- Keep abreast and actively anticipate changes with the European and international regulatory environment
- Previous experience in centralized procedures
- Experienced in developing regulatory strategy
- Demonstrated ability to react appropriately in difficult situations
- Experienced in developing scientific documents for regulatory use
If you are interested in this opportunity, please apply with an updated CV and contact details.